Improving the Childbirth Experience for Women Who Have Undergone Cervical Ripening by Involving Them in the Choice of Ripening Technique

NCT07855146 | Not Yet Recruiting

• 1 other identifier: 2026-02-CHRMT
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-centre, quasi-experimental before-and-after study. Women due to give birth at the participating centre will be informed about the study during their 9th-month antenatal appointment. Only expectant mothers for whom cervical ripening is indicated will be included. During the BEFORE period, cervical ripening will be offered to them according to the method chosen by the healthcare team following a discussion of their case at a team meeting. During the AFTER period, the various possible methods of cervical ripening will be offered to the patient, and the choice of method will be left to her. The participants' experiences will be compared using the QEVA self-assessment questionnaire, completed two days after delivery.

Conditions

Pregnancy; Cervical Ripening; Childbirth

Keywords

Overall experience of childbirth

Outcome Measures

Primary Outcomes (1)

• Score of the first dimension of the QEVA questionnaire

  Total score of the dimension: 'emotions during childbirth' from the Questionnaire Assessing the Childbirth Experience (QACE / Questionnaire d'Evaluation du Vécu de l'Accouchement, QEVA in French). The score ranges from 5 to 20, a higher score means a worse outcome.

  2 days after giving birth

Secondary Outcomes (6)

• Score of the second dimension of the QEVA questionnaire

  2 days after giving birth

• Score of the third dimension of the QEVA questionnaire

  2 days after giving birth

• Score of the fourth dimension of the QEVA questionnaire

  2 days after giving birth

• Procedures for informing patients about their experience of childbirth

  2 days after giving birth

• Impact of the duration of antenatal care on the experience of childbirth

  At baseline

Study Arms (2)

Period before

OTHER

Other: Standard Care (in control arm)

Period after

EXPERIMENTAL

Other: The patient will be offered the various possible methods of inducing cervical ripening, and the choice of method will be left to her

Interventions

The patient will be offered the various possible methods of inducing cervical ripening, and the choice of method will be left to her OTHER

Choice of cervical ripening technique from the following: the 10 mg vaginal dinoprostone delivery system (Propess), oral misoprostol (Angusta®, 25 µg tablets), 1 mg or 2 mg vaginal dinoprostone gel (Prostine) and the extra-amniotic balloon (Cook balloon).

Period after

Standard Care (in control arm) OTHER

Cervical ripening will be offered to them in accordance with the approach chosen by the healthcare team following a discussion of her case at a team meeting.

Period before

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Birthgiving women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged over 18
• Patients who gave their written consent after receiving information to enable them to make an informed decision about the study
• Patients with a medical or non-medical indication for induction of labour who are admitted to the maternity ward of the participating centre

You may not qualify if:

• Patients with a history of uterine scarring (a history of uterine scarring is a contraindication to prostaglandins)
• Patients requiring urgent maturation
• Patients requiring induction of labour in connection with a medical termination of pregnancy or foetal death in utero
• Patients who are unable to complete the questionnaire (due to a lack of proficiency in the language, cognitive impairments, etc.)
• Women deprived of their liberty and/or protected by law

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (1)

CHR METZ-THIONVILLE, Hôpital Femme Mère Enfant

Peltre, 57245, France

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Cristina-Elena DOROFTE, MD

  CHR Metz Thionville Hopital Femme Mère Enfant

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mélanie JUNKE

CONTACT

0033387179886; projet-recherche-clinique@chr-metz-thionville.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, single-centre, quasi-experimental before-and-after study. Women due to give birth at the participating centre will be informed about the study during their 9th-month antenatal appointment. Only expectant mothers for whom cervical ripening is indicated will be included. During the BEFORE period, cervical ripening will be offered to them according to the method chosen by the healthcare team following a discussion of their case at a team meeting. During the AFTER period, the various possible methods of cervical ripening will be offered to the patient, and the choice of method will be left to her. The participants' experiences will be compared using the QEVA self-assessment questionnaire, completed two days after delivery.

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: October 2, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Locations

FR (1)